Distraction Technique to Reduce Discomfort of Transnasal Fiberoptic Laryngoscopy

United Lincolnshire Hospitals NHS Trust

Status: Completed

Conditions: Pain

Treatments: Drug: Local Anesthetics,Topical; Other: Simple distraction technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03191370

280217ArshadFaisal

Details and patient eligibility

About

To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using simple distraction techniques compared to topical anaesthetic spray and a control group that does not receive topical anaesthetic spray or a distraction technique.

Full description

In this randomised controlled study patients will be randomly allocated into one of four groups; the first group will receive topical (co-phenylcaine) anaesthetic spray without distraction, the second group will receive topical (co-phenylcaine) anaesthetic spray with distraction, the thirds group will receive no topical (co-phenylcaine) anaesthetic spray without distraction and the fourth group will receive no topical (co-phenylcaine) anaesthetic spray with distraction. The distraction technique that will be employed is counting backwards from 30 to 1 in even numbers only. All flexible nasal endoscopies will be performed by either of the two most senior clinicians involved in the study. The procedure will be carried out in standard outpatient clinic room setting. Post procedural discomfort assessments will be undertaken using a visual analogue scale (VAS). Power calculations shows that >24 patients would result in an adequately powered study (>80%). Data analysis will be undertaken by SPSS and independent T-tests will be performed to assess for statistical significance.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and Female participants aged 18+
• Patient requires flexible fiberoptic transnasal laryngoscopy.
• Patient has no preferences in relation to which arm of the study they would like to be in.

Exclusion criteria

• Flexible nasal endoscopy not indicated
• Local anaesthetic required for other reasons - e.g. vasoconstrictor effects
• Patient has a clear preference to which group they are randomised to
• Significant sino-nasal disease
• Patient under the age of 18

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Local Anaesthetic, no distraction

Active Comparator group

Description:

Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure.

Treatment:

Drug: Local Anesthetics,Topical

Local Anaesthetic, with distraction

Experimental group

Description:

Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.

Treatment:

Other: Simple distraction technique

Drug: Local Anesthetics,Topical

No Local Anaesthetic without distraction

No Intervention group

Description:

Will receive no local (co-phenylcaine) anaesthetic spray without distraction during the procedure.

No Local Anaesthetic, with distraction

Experimental group

Description:

Will receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention.

Treatment:

Other: Simple distraction technique